Analysis: Fewer approvals may prove R&D is getting tougher

Megan McArdle, the economics editor at The Atlantic, reviews two of the most popular explanations for the meager rate of new drug approvals that plagues biopharma: A tougher bunch of FDA regulators cracking down unreasonably on anything that looks risky vs. a preference for marketing over R&D at profit-hungry companies. Actually, she concludes with data from Tufts, pharma is spending far more than ever on R&D. And there's a bunch of people at the FDA who are actually quite interested in helping along innovative new therapies.

So she offers a new explanation. Maybe, she writes, the whole R&D field is just getting harder to work in. The big fat targets in medicine have largely been hit, and now shots on goal at biopharma are pointed not just at new therapies, but something that is demonstrably better than what's already out there.

"When you're up against nothing, it's relatively easy to show that you're more effective than the alternative," she notes. "But when you're up against already-state-of-the-art treatments, you're looking for small improvements. That means you need huge numbers of patients to generate a statistically significant result. And since good treatments already exist, the safety hurdles are also higher-the FDA is less likely to approve a statin that causes internal bleeding than a pancreatic-cancer drug that does the same.

"Meanwhile, in the areas where we don't have good drugs, we don't have so many easy targets, either. The great hopes for finding drug prospects by decoding the human genome have largely faltered; so far, reading our DNA seems mostly to have taught us how little we still understand about our own biology. So researchers are left with complex problems like cancer, which is really not one disease at all, but several thousand different ways that a human cell can go wrong. Or Alzheimer's: after decades, researchers are still trying to decide whether the disease's signature beta-amyloid plaques in the brain are a cause of dementia, or a side effect."

Whether you agree or disagree with her conclusions, it makes for interesting reading.